MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS4 NBP, SPO2

Model Number 863283

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the device battery burnt up and ruined machine.The device was not in clinical use at the time of the event.There was no adverse event to any patient.

Manufacturer Narrative

Based on the information available philips does not have evidence that issue has occurred, it is noted in the complaint and salesforce case that the customer wanted it filed for insurance purpose but has not shown any evidence.The customer stated that the cause of the reported problem was battery fire.The reported problem has not been confirmed per litigation issue.Based on the information available and results of additional analysis, no further action is necessary at this time.

Event Description

Philips received a complaint on the suresigns vs4 nbp, spo2 (863283) indicating that unit had caught fire from the battery.The device was not in clinical use at the time of the event.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: SURESIGNS VS4 NBP, SPO2
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 2039 concourse drive; st. louis, MO 63146 ; 7243875200
• MDR Report Key: 15698750
• MDR Text Key: 302687431
• Report Number: 1218950-2022-00953
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1